���������������������� KTVR Gardens, 219, Marudha Konar Road, Velandipalayam, Coimbatore - 641 025. Web: www.ktvr.com E-mail: news@ktvr.com Phone: 0422-2445311, 2445451 Mobile: +91-94422-25311, Fax: +91-422-2439990 05-Aug-2010 To The Head of the Institution Respected Sir / Madam, Sub: Seminar on ‘ Career Opportunities in Clinical Research ’ – Reg. We are very glad to invite you to the launch of Cliniminds Coimbatore centre which will be followed by a seminar titled “Career Opportunities in Clinical Research” by Mr. Kamal Shahani , Director, Cliniminds from New Delhi, between 10 AM & 1 PM on Saturday, August 14 th , 2010 at: Sree Purandaradasar Hall 34, Arokiyasamy Road (west), R. S. Puram, Coimbatore – 641 002. We request you to kindly display this letter on your institution’s notice board and also depute your students to attend this programme. For further information, please call 94422-25311 or send an e-mail to tamilnadu@cliniminds.com. The registration fee for each candidate attending this seminar will be Rs. 100/- only . There is no restriction on the number of students participating from each college. Participation certificate will be provided to the candidates. Lunch will be served after the seminar. For registration, candidates are requested to fill the attached entry form and submit them, along with the payment, at the following address, to the undersigned: KTVR Group Hospital Narayana Guru Road, Saibaba Colony, Coimbatore – 641 011. Three entry forms have been attached with this letter. Entry forms can be photocopied and used if more numbers of students are interested. Thanking you, Yours sincerely, Dr J Vijay Venkatraman, MBBS, F. Diab., MBA Head – Cliniminds Tamil Nadu & Puducherry
Dear Participant, Dear Participant, Dear Participant, We are very glad to invite you for the seminar We are very glad to invite you for the seminar We are very glad to invite you for the seminar “ Career Opportunities in Clinical Research ” by “ Career Opportunities in Clinical Research ” by “ Career Opportunities in Clinical Research ” by Mr. Kamal Shahani, Director, Cliniminds, at Mr. Kamal Shahani, Director, Cliniminds, at Mr. Kamal Shahani, Director, Cliniminds, at Sree Purandaradasar Hall, 34, Arokiyasamy Road, Sree Purandaradasar Hall, 34, Arokiyasamy Road, Sree Purandaradasar Hall, 34, Arokiyasamy Road, R S Puram, Coimbatore – 641 002 on Saturday, R S Puram, Coimbatore – 641 002 on Saturday, R S Puram, Coimbatore – 641 002 on Saturday, August 14 th , 2010 between 10 AM and 1 PM. August 14 th , 2010 between 10 AM and 1 PM. August 14 th , 2010 between 10 AM and 1 PM. We request you to register your participation so We request you to register your participation so We request you to register your participation so that we could plan the event. Please fill in the form that we could plan the event. Please fill in the form that we could plan the event. Please fill in the form below and return it to the undersigned, along with below and return it to the undersigned, along with below and return it to the undersigned, along with the entry fee, at the earliest: the entry fee, at the earliest: the entry fee, at the earliest: Name: Name: Name: City: City: City: College/Office: College/Office: College/Office: Qualification: Qualification: Qualification: Mobile: Mobile: Mobile: E-mail: E-mail: E-mail: For further information, please call 94422-25311 For further information, please call 94422-25311 For further information, please call 94422-25311 or e-mail tamilnadu@cliniminds.com. or e-mail tamilnadu@cliniminds.com. or e-mail tamilnadu@cliniminds.com. With thanks & regards, With thanks & regards, With thanks & regards, Dr J Vijay Venkatraman. Dr J Vijay Venkatraman. Dr J Vijay Venkatraman. Head & Faculty, Head & Faculty, Head & Faculty, Cliniminds – TN & Pondy Cliniminds – TN & Pondy Cliniminds – TN & Pondy KTVR Group Hospital, KTVR Group Hospital, KTVR Group Hospital, Narayana Guru Road, Narayana Guru Road, Narayana Guru Road, ENTRY FEE: ENTRY FEE: ENTRY FEE: Saibaba Colony, Saibaba Colony, Saibaba Colony, Rs. 100/- only Rs. 100/- only Rs. 100/- only Coimbatore – 641 011. Coimbatore – 641 011. Coimbatore – 641 011.
Clinical Research – Fastest Growing Industry in India Clinical Research is an indispensable part of the drug discovery & development process to ensure the safety and efficacy of any new drug. In today’s global scientific era, clinical trials are the mainstay for bringing newer and better drugs to market. Although a set of robust guidelines and regulations are available to govern the conduct of clinical trials in any country, the conduct of clinical research is also looked upon as a area of humanitarian concern. Drug Discovery & Development-An Outline Clinical Research Definition : Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease. Steps in Clinical research : Initiation IND Submission- Investigative New Drug Application to the respective Regulatory Authority Step I Phase I Clinical Trial- first studies conducted in humans to verify safety and tolerability of the candidate drug in humans and typically take six to nine months Step II Phase II Clinical Trial determines safety and effectiveness of the drug in treating the condition and establishes the minimum and maximum effective dose. This phase of development generally takes from six months up to three years Step III Phase III Clinical Trial determines safety and efficacy with several hundred to thousands of volunteer patients suffering from the condition the investigational drug treats. This Phase generally takes from one to four years. NDA Submission- New Drug Application to the respective Regulatory Authority to Request to Market market the candidate drug. Step IV Phase IV Clinical Trials –Post Marketing Surveillance is an expand testing of a proven drug to broader patient populations and compare the long-term safety,effectiveness and/or cost of the drug to other marketed drugs available to treat the same condition. India Hub of Clinical Research The USD64 billion global Drug research industry is witnessing a transition as life science companies are turning toward emerging markets in Asia, Latin America and Eastern Europe, to pursue clinical research. India is becoming favored destination due to several factors, viz. strong regulatory environment, significantly lower cost, fast growing pharmaceutical industry, large genetically diverse and treatment naïve population, patient profile aligned with the key research focus of global pharmaceutical industry such as cardiology, oncology, central nervous system, Anti-infective, asthma, rapidly growing number of world class medical & diagnostics facilities, investigators and abundant availability of scientific talent. Finally, India’s ability to offer end to end services in Clinical Research covering trials, data management, medical writing, biostatistics, Pharmacovigilance and Central
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